NCT03332264

Sequent Please Drug Coated Balloons Versus Primary Stent Application in Long SFA Lesions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: InnoRa GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with peripheral artery disease will be treated with either drug coated balloon catheter, drug coated stent or uncoated stent.

Detailed description

Patients with chronic stenotic or occlusive atherosclerotic disease and lesions of at least 13 cm length in the SFA or Arteria poplitea segment 1 will be randomized to either treatment with paclitaxel coated balloon catheter, paclitaxel coated stent or bare nitinol stent. Vessel patency will be evaluated by quantitative angiography after 12 months. Clinical follow-ups will be done until 36 months post-intervention.

Conditions

• Stenosis
• Occlusion
• Restenosis

Interventions

Type	Name	Description
DEVICE	SeQuent Please OTW	Dilatation of occluded or highly stenosed vessel with paclitaxel-coated balloon catheter
DEVICE	Eluvia Vascular Stent System	Dilatation of occluded or highly stenosed vessel with paclitaxel-coated stent
DEVICE	Nitinol stent	Dilatation of occluded or highly stenosed vessel with uncoated bare nitinol stent

Timeline

• Start date: 2017-03-30
• Primary completion: 2022-01-31
• Completion: 2023-12-12
• First posted: 2017-11-06
• Last updated: 2024-02-15

Locations

10 sites across 2 countries: Austria, Germany